12 Noncompliance documentation To document a deviation: Write a Note to File, unless the deviation can be explained on another document Indicate on th
{"Image DocumentName": "Noncompliance documentation", "Image ImageDescription": "To document a deviation: Write a Note to File, unless the deviation can be explained on another document. Indicate on the Note to File what was done to correct the mistake and what was done to prevent this mistake from happening again. To document a violation: Write down the violation in the Source Data and/or the CRF. Discuss with the sponsor the steps that must be followed. Fill in a Protocol Violation form and indicate which steps are taken to prevent the problem from happening again. Send a copy to the sponsor and file the original in the ISF. Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial. Versie: 06-dec-2012.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}